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dabrafenib/trametinib

Phase 2

Anaplastic Thyroid Cancer | Small molecule | Oncology |Novartis AG|Last Updated: Oct 12, 2023

Success Probability
Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
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Market & Valuation
rNPV $3.2B
Market Size $9.4B
Revenue Basis $1.6B
Competitors 6
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Trial Design
UNCONTROLLEDDMCBiomarker
Total Trials1
Total Enrollment20
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT06079333NEO- and Adjuvant Targeted Therapy in Braf-mutated Anaplastic Cancer of the Thyroid (NEO-ATACT Study)PHASE2 RECRUITING 20Jan 1, 2023Jan 1, 2028Oct 12, 20231 Netherlands
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Study Endpoints
Primary Endpoints
primary endpoint of the study will be R0 resection rate (efficacy).
after 6-12 weeks braf/mek-inhibition
Secondary Endpoints
Neo-adjuvant and adjuvant treatment related toxicity of dabrafenib/trametinib (according to CTCAE v. 5.0)
during 1 year of treatment with braf/mek-inhibition
30-day postoperative surgical complications
within 30 days after surgery
Histopathological response after neo-adjuvant treatment
6-12 weeks neo-adjuvant braf/mek-inhibition
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Study Design & Arms
AllocationNA
MaskingNONE
ModelSINGLE_GROUP
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
neo-adjuvant and adjuvant braf/mek-inhibitionEXPERIMENTALParticipants will undergo neo-adjuvant treatment with dabrafenib/trametinib. After 6 weeks of BRAF/MEK inhibitors, participants will undergo an evaluation of resectability. If the tumor is resectable, patients undergo tumor resection. If not resectable, neo-adjuvant treatment continues for another 6 weeks followed by a new evaluation. All resected patients receive adjuvant dabrafenib/trametinib up to a total treatment duration of 52 weeks. If resection is not possible, patients will continue on dabrafenib/trametinib.
Interventions
NameTypeDescription
dabrafenib/trametinibDRUGbraf/mek-inhibition
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Eligibility Criteria
Age Range18 Years — N/A
SexALL
Healthy VolunteersNo
Study Sites1

Inclusion Criteria: 1. Informed consent. 2. Age over 18 years old. 3. World Health Organization (WHO) Performance Status 0 or I. 4. Histologically confirmed ATC (centrally reviewed). 5. Confirmed presence of BRAFV600E/K mutation in primary tumor tissue. 6. No distant metastases (M0). 7. Free or sec...

Countries:Netherlands
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Recent Changes (Last 90 Days)
LOWMay 24, 2026NCT06079333studyFirstPostDate: changed